Abstract
The current study evaluated the efficacy and safety of a denosumab biosimilar, QL1206 (60 mg), compared to placebo in postmenopausal Chinese women with osteoporosis and high fracture risk. At 31 study centers in China, a total of 455 postmenopausal women with osteoporosis and high fracture risk were randomly assigned to receive QL1206 (60 mg subcutaneously every 6 months) or placebo. From baseline to the 12-month follow-up, the participants who received QL1206 showed significantly increased bone mineral density (BMD) values (mean difference and 95% CI) in the lumbar spine: 4.780% (3.880%, 5.681%), total hip :3.930% (3.136%, 4.725%), femoral neck 2.733% (1.877%, 3.589%) and trochanter: 4.058% (2.791%, 5.325%) compared with the participants who received the placebo. In addition, QL1206 injection significantly decreased the serum levels of C-terminal crosslinked telopeptides of type 1 collagen (CTX): −77.352% (−87.080%, −66.844%), and N-terminal procollagen of type l collagen (P1NP): −50.867% (−57.184%, −45.217%) compared with the placebo over the period from baseline to 12 months. No new or unexpected adverse events were observed. We concluded that compared with placebo, QL1206 effectively increased the BMD of the lumbar spine, total hip, femoral neck and trochanter in postmenopausal Chinese women with osteoporosis and rapidly decreased bone turnover markers. This study demonstrated that QL1206 has beneficial effects on postmenopausal Chinese women with osteoporosis and high fracture risk.
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Acknowledgements
We thank the study participants for their invaluable cooperation. The study was sponsored by Qilu Pharmaceutical Co. Ltd, Jinan, China.
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ZLZ, AJC, QC, DHT, JMY, BWW, YNH, LM, QZ, HY, SGY, KQZ, XLZ, HL, YP, ZY, RCD, LH, LC, YFS, ZLD, LY, BB, MZ, YLC, YKZ, ZJL, ZZ, CQY, YBL, GW, and CCH conceived and designed research; HZ, JMG, ZLZ, AJC, QC, DHT, JMY, BWW, YNH, LM, QZ, HY, SGY, KQZ, XLZ, HL, YP, ZY, RCD, LH, LC, YFS, ZLD, LY, BB, MZ, YLC, YKZ, ZJL, ZZ, CQY, YBL, and GW collected data and conducted research; HZ, JMG, ZLZ, AJC, QC, DHT, JMY, BWW, YNH, LM, QZ, HY, SGY, KQZ, XLZ, HL, YP, ZY, RCD, LH, LC, YFS, ZLD, LY, XXL, and ZJW analysed and interpreted data; HZ, JMG, ZLZ, AJC, and QC wrote the initial paper; HZ, JMG, ZLZ, AJC, QC, DHT, JMY, BWW, YNH, LM, QZ, HY, SGY, KQZ, XLZ, HL, YP, ZY, RCD, LH, LC, YFS, ZLD, LY, BB, MZ, YLC, YKZ, ZJL, ZZ, CQY, YBL, and GW revised the paper; ZLZ was primarily responsible for the final content. All authors read and approved the final paper.
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CCH, ZJW, and XXL are employees of the study sponsor (Qilu Pharmaceutical Co., Ltd) at the time of study. The other authors declare that they have no competing interests.
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This study was approved by the independent ethics committees of 31 participating sites.
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Zhang, H., Gu, Jm., Chao, Aj. et al. A phase III randomized, double-blind, placebo-controlled trial of the denosumab biosimilar QL1206 in postmenopausal Chinese women with osteoporosis and high fracture risk. Acta Pharmacol Sin 44, 446–453 (2023). https://doi.org/10.1038/s41401-022-00954-y
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DOI: https://doi.org/10.1038/s41401-022-00954-y
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